UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019115 |
|---|---|
| Receipt number | R000022086 |
| Scientific Title | Pathophysiological roles of atherosclerotic carotid plaque phenotypes and bioactive substances in patients undergoing carotid endarterectomy |
| Date of disclosure of the study information | 2015/09/25 |
| Last modified on | 2015/10/01 19:46:19 |
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Basic information
Public title
Pathophysiological roles of atherosclerotic carotid plaque phenotypes and bioactive substances in patients undergoing carotid endarterectomy
Acronym
Pathophysiological characteristics of carotid plaque and circulating monocytes
Scientific Title
Pathophysiological roles of atherosclerotic carotid plaque phenotypes and bioactive substances in patients undergoing carotid endarterectomy
Scientific Title:Acronym
Pathophysiological characteristics of carotid plaque and circulating monocytes
Region
| Japan |
Condition
Condition
1. Atherosclerosis
2. Stroke
3. Carotid stenosis
4. Diabetes
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Vascular surgery | Neurosurgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will examine the expression levels of a series of bioactive substances such as inflammatory cytokines in carotid plaque of patients undergoing carotid endarterectomy. In addition, we will assess the relationship of pro-inflammatory/anti-inflammatory phenotypes of carotid plaque with glucose metabolism and pro-inflammatory/anti-inflammatory phenotypes of circulating monocytes, which will help us to develop new strategies for the prevention and control of atherosclerotic cardiovascular diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
inflammatory mediators
IL-6,IL-10,TNFalfa,MCP-1
activation/inflammatory markers in plaque and peripheral blood monocytes
MHC-II, CD86, Dectin-1, CD206, CD16, CD68
Key secondary outcomes
body weight,BMI,waist circumference,blood pressure,HbA1c,FPG,TC,TG,LDL-C,HDL-C, UA,BUN,Cre
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Outpatients undergoing carotid endarterectomy in the Department of Neurosurgery of our hospital
2. Patients who are able to attend the hospital
3. Age: 20 years of age and older, and below 80 years old
4. Patients providing written informed consent
Key exclusion criteria
1. Subjects who have been determined to be unsuitable for the attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriko Satoh-Asahara |
Organization
National Hospital Organization,
Kyoto Medical Center
Division name
Clinical Research Institute
Zip code
Address
1-1 Mukaihata-cho,Fukakusa,Fushimi-ku,Kyoto
TEL
075-645-9161
nsato@kyotolan.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Satoh-Asahara |
Organization
National Hospital Organization, Kyoto Medical Center
Division name
Clinical Research Institute
Zip code
Address
1-1 Mukaihata-cho,Fukakusa,Fushimi-ku,Kyoto
TEL
075-641-9161
Homepage URL
nsato@kyotolan.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization,
Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization,
Kyoto Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2011 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is prospective cohort study. We will investigate the patients undergoing carotid endarterectomy from March 1st, 2011, to February 29th, 2014, in the Department of Neurosurgery of Kyoto Medical Center, who meet the selection criteria and whose informed consent is obtained. In this study, the expression levels of a series of inflammatory/anti-inflammatory mediators (TNF-alpha, IL-6, IL-10, MCP-1, TREM2) will be quantified in carotid plaque obtained from surgical patients undergoing carotid endarterectomy by real-time PCR, and the protein levels of inflammatory/anti-inflammatory mediators in blood samples will be determined by ELISA.
In addition, anthropometric and metabolic parameters will be measured (height, body weight, waist circumference, body mass index, systolic and diastolic blood pressures, HbA1c, FPG, TG, TC, LDL-C, HDL-C, UA, BUN, Cre). Circulating monocyte fractions will be isolated from the peripheral blood samples by MACS and subjected to the measurement of gene expression of the inflammatory/anti-inflammatory mediators (TNF-alpha, IL-6, IL-10, MCP-1, MHC-II, CD86, Dectin-1, CD206, CD16, CD68, TREM2).
These studies will reveal the mechanisms underlying the development of atherosclerotic plaque in patients with carotid stenosis and/or stroke, which will help us to develop new strategies for evaluating the progression of atherosclerosis and the postoperative prognosis.
Management information
Registered date
| 2015 | Year | 09 | Month | 25 | Day |
Last modified on
| 2015 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022086
| Research Plan | |
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